Methods of producing an intermittent urinary catheter package

ABSTRACT

A package or container for a catheter having a catheter tube with a proximal end provided with a catheter outlet and a distal opening at a distal end thereof. A gel receptacle is provided with a cavity for holding an amount of a lubricating agent, and the catheter tube extends therethrough. The gel receptacle is configured such that as the catheter is withdrawn from a stored position therein, a leading tip of the catheter is immersed in the lubricating agent, thus automatically coating the leading tip. The gel receptacle may be held within a rigid body or may be a standalone item packaged in a sterile bag solely with the catheter. A side wall of the gel receptacle is deformable so that as the catheter is withdrawn proximally the side wall is collapsed inward to displace the lubricating agent gel and coat an exterior surface of the catheter tube.

RELATED APPLICATION INFORMATION

The present application is a continuation of application Ser. No.15/619,017 filed Jun. 9, 2017 now U.S. Pat. No. 9,833,592 issued Dec. 5,2017, entitled “AUTOMATIC GEL APPLYING CONTAINER FOR AN INTERMITTENTURINARY CATHETER”, which is continuation-in-part of application Ser. No.15/377,256 filed Dec. 13, 2016, titled “AUTOMATIC GEL CONTAINER FOR ANINTERMITTENT URINARY CATHETER”, now U.S. Pat. No. 9,687,629 issued Jun.27, 2017.

NOTICE OF COPYRIGHTS AND TRADE DRESS

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. This patent document may showand/or describe matter which is or may become trade dress of the owner.The copyright and trade dress owner has no objection to the facsimilereproduction by anyone of the patent disclosure as it appears in thePatent and Trademark Office patent files or records, but otherwisereserves all copyright and trade dress rights whatsoever.

FIELD

Embodiments of the present invention relates to a sterile packagehousing a catheter, e.g., a urethral catheter, which can be used for(intermittent) self-catheterization by a patient.

BACKGROUND

Intermittent catheters are typically used by patients suffering fromurinary incontinence or by individuals unable to have voluntaryurination. In our highly mobile culture, the ability to have the freedomto leave home for the day or longer is an important part of life. Toaccommodate this need, single use catheters have been developed to allowpatients to perform self-catheterization. These catheters and theirdrainage tubes typically have a considerable length and are packaged inan elongated condition. It can require a considerable amount of space tostore and transport enough catheters to accommodate a day long outing.

A gel container is used as a means to apply gel to a urology catheterupon withdrawal of the catheter from a package. The container holds thegel until needed and acts as a reservoir of gel for the catheter. U.S.Pat. Nos. 6,578,709 and 6,090,075 disclose packaged catheters which maybe extended out of the package through a gel chamber so as to coat theleading end of the catheter. British patent application GB-A-2 319 507also discloses a packaged catheter with a lubricant activating liquidtherein. Likewise, U.S. Pat. No. 6,848,574 discloses a storage packagewith a catheter and a wetting liquid in the storage package. Whenneeded, the leading end of the catheters disclosed above are pushed outof their containers, which may then be used as urine collectors.

Typically, the gel container is made of a flexible material like moldedsilicone. If the container is assembled into a rigid package there is noway for the user to manipulate the container to ensure adequate gelcoverage of the distal (tip) end of the catheter.

The Cure Twist available from Cure Medical of Newport Beach, Calif. is acompact female length catheter packaged in a rigid tube package with aninternal, flexible gel receptacle molded of silicone rubber. The gelreceptacle holds lubricating gel in storage and applies it to thecatheter tubing as the catheter is withdrawn from the package. U.S. Pat.No. 8,181,778 discloses such a rigid container for a catheter having ashortened tube with a leading end and a proximal end provided with acatheter outlet or connector. The user removes the catheter for use,either by joining the connector to a collection bag or other collectiondevice or by simply using the catheter while sitting on the toilet. Thecatheter is lubricated and ready to use directly from the package.

SUMMARY OF THE INVENTION

Embodiments of the present invention seek to provide an enhanced packagefor a (urethral) catheter, suitable for everyday use by a patient.

In one embodiment, a package or container for a urethral catheterincludes a gel receptacle with a cavity for holding an amount of alubricating agent, and the catheter tube extends therethrough. The gelreceptacle is configured such that as the catheter is withdrawn from astored position therein, a leading tip of the catheter is immersed inthe lubricating agent, thus automatically coating the leading tip. Thegel receptacle may be held within a rigid body or may be a standaloneitem packaged in a sterile bag solely with the catheter. A side wall ofthe gel receptacle may be deformable so that as the catheter iswithdrawn proximally the side wall is collapsed inward to displace thelubricating agent gel and coat an exterior surface of the catheter tube.The side wall may be manually deformed inward or may be molded to have acollapsed relaxed state.

The gel receptacle solutions described herein allow for a better gelcoating on the catheter regardless of the outer package; i.e., rigid orflexible. The automatic nature of the gel application allows for goodgel distribution even if the user has limited finger strength ordexterity. The gel packet would not have to be manipulated at all.

In accordance with embodiments of the present invention, a package isprovided for a catheter that includes at least the following: a catheterhaving a catheter tube with a distal end and a proximal end, theproximal end being provided with a catheter connector; a main body forholding the catheter; a cap for closing off the main body, and a gelreceptacle positioned inside the main body, the gel receptacle beingprovided with a cavity for holding an amount of gel-like lubricatingagent, and including a distal opening at a distal end, and a proximalopening at a proximal end, the distal opening diameter corresponding toa catheter diameter, and the proximal opening diameter being larger thanthe catheter diameter.

The present invention is an improvement to the gel receptacle thatensures gel coverage of the tip section of the catheter to facilitateuser comfort. The improvement can be done in a number of ways by use ofa specially shaped gel container or by use of an internal feature in thegel container that tips the distal end of the catheter up into a reserveof gel just prior to exit from the gel container.

One aspect of the application is a catheter package comprising a rigidmain body defining an inner space, and a cap provided at a proximal endof the main body which closes off a proximal end of the inner space. Acatheter is received in the annular cavity of the main body, thecatheter including a flexible catheter tube having a distal tip and atleast one discharge opening proximate the distal tip, and a catheteroutlet provided at a proximal end of the catheter tube. A gel receptacleis held in the inner space of the main body, the gel receptacle defininga cavity therein containing a lubricating agent. The gel receptacle hasa distal opening at a distal end thereof with an inner diameterapproximately the same as an outer diameter of the catheter tube, and aproximal opening at a proximal end thereof with an inner diametergreater than the outer diameter of the catheter tube. The catheter isstored in the inner space of the main body with the distal tip of thecatheter tube positioned distal to the gel receptacle and the catheteroutlet positioned proximal to the gel receptacle such that withdrawingthe catheter proximally from the main body coats an exterior surface ofthe catheter tube with the lubricating agent. Further, the gelreceptacle is configured such that the distal tip of the catheter tubedisplaces laterally from a straight line therethrough when it clears thedistal opening to enhance lubricating agent coating of the distal tip.

A method of lubricating a catheter distal tip stored in a rigid packageis also disclosed. The method includes the step of providing a catheterpackage comprising a rigid main body defining an inner space, and a capprovided at a proximal end of the main body which closes off a proximalend of the inner space. A catheter is received in the annular cavity ofthe main body, the catheter including a flexible catheter tube having adistal tip and at least one discharge opening proximate the distal tip,and a catheter outlet provided at a proximal end of the catheter tube. Agel receptacle is held in the inner space of the main body, the gelreceptacle defining a cavity therein containing a lubricating agent, thegel receptacle having a distal opening at a distal end thereof with aninner diameter approximately the same as an outer diameter of thecatheter tube, and a proximal opening at a proximal end thereof with aninner diameter greater than the outer diameter of the catheter tube. Thecatheter is stored in the inner space of the main body with the distaltip of the catheter tube positioned distal to the gel receptacle and thecatheter outlet positioned proximal to the gel receptacle such thatwithdrawing the catheter proximally from the main body coats an exteriorsurface of the catheter tube with the lubricating agent. The methodincludes the step of withdrawing the catheter from the inner space ofthe main body such that the distal tip of the catheter tubeautomatically displaces laterally within the gel receptacle to enhancelubricating agent coating of the distal tip.

The gel receptacle may be generally tubular and the distal and proximalopenings are offset from each other relative to a longitudinal axisthrough the gel receptacle so that the catheter must form a curvethrough the gel receptacle. The distal opening may be formed in a sidewall of the gel receptacle and the proximal opening is formed in an endwall of the gel receptacle, or both the distal and proximal openings areformed in end walls of the gel receptacle. The distal and proximalopenings are preferably positioned at opposite lateral sides of thelongitudinal axis.

The gel receptacle may also be shaped so as to form an inward bulge onone side which extends into a straight line path for the catheter tubeextending between the distal and proximal openings so as to deform thecatheter tube through the gel receptacle. The gel receptacle may begenerally tubular or serpentine shaped. In either case, both the distaland proximal openings are desirably centered in end walls of the gelreceptacle.

Alternatively, the gel receptacle may include a spring finger whichextends into a straight line path for the catheter tube extendingbetween the distal and proximal openings so as to bias and deform thecatheter tube through the gel receptacle.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a longitudinal sectional view through a sterile container ofthe prior art for an intermittent urinary catheter;

FIG. 2A is a schematic sectional view of a gel receptacle of the priorart catheter container of FIG. 1, and FIG. 2B shows a catheter leadingend within the gel receptacle during withdrawal from the container;

FIG. 3A is a schematic sectional view of a gel receptacle of the presentapplication for use in a catheter container, and FIG. 3B shows acatheter leading end during withdrawal through the gel receptacle whichhas offset openings to ensure gel coating of the leading end;

FIG. 4A is a schematic sectional view of another alternative gelreceptacle for use in a catheter container of the present application,and FIG. 4B shows a catheter leading end during withdrawal through thegel receptacle which also has offset openings to ensure gel coating ofthe leading end;

FIG. 5A is a schematic sectional view of a still further gel receptaclefor a catheter container of the present application, and FIG. 5B shows acatheter leading end during withdrawal through the gel receptacle whichhas a serpentine configuration to ensure gel coating of the leading end;

FIG. 6A is a schematic sectional view of still another gel receptacle ofthe present application for use in a catheter container, and FIG. 6Bshows a catheter leading end during withdrawal through the gelreceptacle which has an internal fulcrum to ensure gel coating of theleading end;

FIG. 7A is a schematic sectional view of a gel receptacle of anothercatheter container of the present application, and FIG. 7B shows acatheter leading end during withdrawal through the gel receptacle whichhas an internal spring finger to ensure gel coating of the leading end;

FIG. 8A is a schematic sectional view of another gel receptacle of thepresent application for a catheter container, and FIG. 8B shows acatheter leading end during withdrawal through the otherwise rigid gelreceptacle which has a squeezable segment to ensure gel coating of theleading end;

FIGS. 9A and 9B are perspective views of an alternative gel receptacle;

FIG. 10A is a partial sectional view through the gel receptacle of FIGS.9A and 9B with a urinary catheter stored therein, and FIG. 10B shows thegel receptacle during retraction of the catheter therefrom;

FIGS. 11A and 11B are perspective views of an alternative gelreceptacle, while FIGS. 11C-11F are several orthogonal and sectionalviews illustrating an internal finger or flap therein;

FIG. 12A is a perspective view of a single-use package containing aurinary catheter stored with a gel receptacle of the presentapplication, such as that shown in FIGS. 11A-11F, while FIGS. 12B and12C show a urinary catheter stored within the gel receptacle and beingremoved therefrom, respectively;

FIGS. 13A and 13B are perspective views of a further gel receptaclehaving a collapsible indented section that helps apply gel to a urinarycatheter, while FIGS. 14A-14D are several orthogonal and sectional viewsillustrating an inner structure of the gel receptacle includingprotrusions in the indented section;

FIG. 15A is a perspective view of another single-use package containinga urinary catheter stored with a gel receptacle of the presentapplication, such as that shown in FIGS. 13-14, while FIGS. 15B and 15Cshow a urinary catheter stored within the gel receptacle having acollapsible indented section and being removed therefrom, respectively;

FIGS. 16A and 16B are perspective views of a still further gelreceptacle also having a collapsible indented section that helps applygel to a urinary catheter, while FIGS. 17A-17D are several orthogonaland sectional views illustrating an inner structure of the gelreceptacle including protrusions in the indented section;

FIGS. 18A-18C are sectional and interviews of another gel receptacle ofthe present application having a collapsible portion with inner fins;and

FIGS. 19A and 19B are longitudinal sectional views of the gel receptacleof FIGS. 18A-18C with a catheter stored therein and being removedtherefrom, respectively.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT Description

Embodiments of the present invention aim to provide an easy to use andeasy to carry solution for providing a medical device in the form of acatheter. As an example, the medical device is a urethral catheter thatallows a patient or helper to empty the bladder of the patient.Embodiments of the present invention provide for a rigid package inwhich a catheter 30 such as a urethral catheter can be carried, andwhich is ready for use when taken from the package. Urethral catheter 30may be used for intermittent self-catheterization.

More particularly, the sterile rigid catheter packages described hereincontain a gel receptacle which is filled with a lubricant gel. Thecatheter is stored in a manner that its flexible distal tube is passedthrough the gel receptacle with a leading tip housed beyond the gelreceptacle and within a closed distal end of the package. To operate, auser grasps a proximal end of the catheter and withdraws the cathetertube through the gel receptacle to coat it with lubricant gel. Thepresent application discloses a number of different gel receptacleswhich may be used in a variety of such rigid catheter packages and whichimprove the coverage of gel on the leading tip of the catheter. As such,the application comprises both improved gel receptacles as well asimproved packages with the gel receptacles therein.

FIG. 1 illustrates a cross sectional view of a prior art intermittentcatheter container 20 such as shown in U.S. Pat. No. 8,181,778, with allelements assembled. Catheter container 20 includes a pen-like rigid andgenerally hollow tubular main body 22 which is closed off at a distalend thereof, and which can be closed off at a proximal, open end usingcap 24. The rigid cap 24 can be attached to the main body 22 usingvarious attachment/locking methods, such as a screw thread, a press fit,a bayonet closure or a clamping arrangement. The cap 24 desirably has aplurality of openings (not shown) to permit the introduction of asterilizing gas into the catheter package.

The cross-sectional view of main body 22 shows a proximal first part 26a, a middle second part 26 b and distal third part 26 c, which haverespective diameters as described in U.S. Pat. No. 8,181,778.Preferably, first part 26 a has a first inner diameter which is lessthan second inner diameter of second part 26 b, and third part 26 c hasa third inner diameter which is less than second inner diameter ofsecond part 26 b. In other words, the middle second part 26 b has alarger diameter than either of the proximal or distal parts.

As illustrated, a urethral catheter 30 is stored in a sterile conditionwithin the main body 22 with the cap 24 on. At a proximal end thereof,catheter 30 is provided with a catheter outlet 32, which may be used asan outlet funnel or as a connector to attach the catheter 30 to acollection bag or other collection device. Catheter 30 includes aflexible catheter tube 34 provided with a rounded tip 35 on a distal endand one or more discharge openings 36 proximate the tip. Openings 36 areprovided with rounded and or polished rims 38, such that the entry ofurethral catheter tube 34 into the urethral tract of a patient is ascomfortable as possible for the patient. The first part 26 a of the mainbody receives the cap 24, the second part 26 b holds a gel receptacle40, and the third part 26 c holds the elongated catheter tube 34 of thecatheter 30.

The rigid nature of the container 20 and short length of the catheter 30therein make the sterile package formed by the assembly highly portableand conveniently stored in a purse or even pocket.

The cap 24 contains the proximal outlet 32 of the catheter 30 and may bemade of a transparent material, which allows inspection of the outlet 32(which can, e.g., show size or other indicia, markings, etc.).

The dimensions of container 20 (or more specifically, the internaldimensions of main body 22 and cap 24) are adapted to allow storage ofthe entire catheter 30 (which may have varying dimensions). A length ofthe container 20 desirably corresponds closely to the length of catheter30, and is preferably slightly greater than the length of catheter 30 sothat the package closely surrounds the entire catheter 30. In accordancewith embodiments, catheter 30 can have a length in a range of betweenabout 10-15 cm, which makes catheter 30 especially suited for use withfemale patients.

A gel receptacle 40 is provided and positioned in second part 26 b ofmain body 22 as illustrated schematically in the enlargedcross-sectional view of FIG. 2A. Gel receptacle 40 is illustrated as asingle generally tubular element provided with cavity 42 in which anamount of a gel-like lubricant agent is stored. As seen in FIG. 2A, gelreceptacle 40 includes distal opening 44 at a distal end thereof, andproximal opening 46 at a proximal end thereof. Distal opening 44 hasdiameter corresponding generally to outer diameter of catheter tube 34,while proximal opening 46 has diameter slightly greater than the outerdiameter of catheter tube 34. The distal and proximal openings 44, 46are aligned with each other along a longitudinal centerline 50 extendingbetween the distal and proximal ends of the gel receptacle 40. Whentaking or otherwise removing catheter 30 in a proximal direction out ofthe package (to the right as indicated by movement arrow in FIG. 2A), alayer 48 of the gel-like lubricant extrudes through proximal opening 46and is deposited on the outside surface of the catheter for use.

FIG. 2B shows the catheter tube 34 retracted further in a proximaldirection so that the leading tip 35 is within the gel receptacle 40.Because of its thixotropic properties, the gel adheres to the exteriorsides of the catheter tube 34 as at 48, but often a tunnel 52 is formedin the gel material behind the catheter as it is pulled from thepackage. Consequently, the leading tip 35 of the catheter does notreceive consistently good gel coverage. Application of lubricating gelto the leading tip 35 is important; the tip 35 being the first part ofthe catheter to be inserted into the urethra. If the very tip 35 of thecatheter receives no gel it could make insertion more difficult for someusers. In addition, this problem is aggravated with longer lengths ofcatheters, for instance a male length catheter.

FIGS. 3A and 3B are schematic sectional views of a gel receptacle 140 ofthe present application through which a catheter tube of a catheter 130passes. The gel receptacle 140 may be positioned in the cathetercontainer 20 in place of the gel receptacle 40 shown and described abovewith reference to FIGS. 1 and 2A-2B, or in other configurations ofcatheter packaging which have a rigid outer housing and requirewithdrawal of the catheter in a proximal direction from the container.Alternatively, the gel receptacle 140 may be housed in a more flexiblecontainer, or as a standalone device within a flexible package. The gelreceptacle 140 also has a cavity 142 filled with a lubricant gel, adistal opening 144 formed in a distal end wall, and a proximal opening146 formed in a proximal end wall, through both of which the tube of thecatheter 130 passes. As with the prior art, withdrawal of the catheterin a proximal direction pulls the leading tip 135 through the gelreceptacle 140 to coat it with lubricating gel.

In contrast to the prior art, the openings 144, 146 are offset from eachother, such as forming one or both offset relative to a longitudinalcenterline 150 of the gel receptacle 140. In the illustrated embodiment,the distal opening 144 is offset in one lateral direction (down in thefigure) from the longitudinal centerline 150, while the proximal opening146 is offset in the opposite lateral direction (up in the figure).Consequently, the flexible tube of the catheter 130 deflects wheninserted through the two openings 144, 146 to form the slightlyserpentine shape of FIG. 3A.

FIG. 3B shows the catheter leading end 135 within the gel receptacle 140during withdrawal therethrough, and a tunnel 152 thus formed behind it.However, due to the offset openings, once the leading end 135 isretracted past the distal opening 144 it tends to be displaced laterallyas indicated by the movement arrow due to the inherently elastic natureof the catheter tube. This ensures the leading end 135 diverges from thetunnel 152 and into the lubricating gel, automatically coating theleading tip when the catheter is removed from the packaging.

FIG. 4A is a schematic sectional view of a gel receptacle 240 of anotheralternative catheter container of the present application. The gelreceptacle 240 also has openings 244, 246 that are offset from eachother. In contrast to the embodiment of FIG. 3A, a distal opening 244 isformed in a side wall 247 of the receptacle 240 rather than in a distalend wall. The proximal opening 246 is located in a proximal end wall andoffset from a centerline in the opposite lateral direction from the sidewall 247 to maximize the lateral offset distance between the twoopenings 244, 246.

FIG. 4B shows the catheter leading end 235 within the gel receptacle 240during withdrawal of the tube of the catheter 230 in a proximaldirection therethrough. As before, once the leading end 235 clears thedistal opening 244 it tends to be displaced laterally upward asindicated by the movement arrow out of a gel tunnel 252 trailing thecatheter and into the center of the gel receptacle 240. This movement iscaused by the inherently elastic nature of the catheter tube and ensuresthe leading end 235 is coated with lubricating gel, automaticallycoating the leading tip when the catheter is removed from the packaging.

FIGS. 5A and 5B show a gel receptacle 340 of a still further cathetercontainer which has a serpentine catheter pathway to ensure gel coatingof the leading end. More particularly, the receptacle 340 curves upwardin the middle to an apex 360 on one side and an inward bulge 362 on theother which extends into a straight line path for the tube of thecatheter 330 extending between the distal and proximal openings 344,346. As such, the tube of the catheter 330 is bowed upward from contactwith the inward bulge 362. Distal and proximal openings 344, 346 arecentered in each respective end wall, or may be offset toward the inwardbulge 362. As the tube of the catheter 330 is withdrawn in a proximaldirection such as in FIG. 5B, the leading tip 335 clears the distalopening 344 and is biased so as to displace laterally upward into thelubricating gel, automatically coating the leading tip when the catheteris removed from the packaging.

As mentioned above, the gel receptacle 340 may be supplanted into theprior art container 20 of FIG. 1. Of course, if the outer shape of thegel receptacle 340 is modified from the prior art receptacles, then somemodification of the surrounding rigid housing would be required toreceive the unconventional shape of the receptacle. The presentapplication contemplates such modifications.

FIGS. 6A and 6B show a gel receptacle 440 which is generally tubular asbefore but has a crease in one side wall forming an internal fulcrum 460to ensure gel coating of the leading end. As before, the flexible tubeof the catheter 430 passes through distal and proximal end openings 444,446. The fulcrum 460 comprises an inward bulge in one side wall thatextends into a straight line path for the tube of the catheter 430extending between the distal and proximal openings 444, 446 so as todeform the tube of the catheter 430 at that point. As a consequence,when the catheter 430 is withdrawn in a proximal direction as in FIG.6B, the leading tip 435 clears the distal opening 444 and is biasedlaterally so as to displace it upward out of the trailing gel tunnel 452and into the lubricating gel. This automatically coats the leading tip435 when the catheter is removed from the packaging.

FIGS. 7A and 7B show a still further catheter container gel receptacle540 of which has an internal spring finger 560 to ensure gel coating ofthe leading end. The finger 560 is shown angled radially and axiallyinward from a proximal corner 562 of the receptacle 540, though itsplacement and orientation may be altered. The length and angle of thefinger 560 is such that it permits insertion of the tube of the catheter530 in a distal direction when assembling the catheter container, andexerts a radially inward force to the catheter. When the catheter 530 iswithdrawn, as shown in FIG. 7B, the leading tip 535 thereof eventuallyclears a distal opening 544. The bias force of the spring finger 560displaces the leading tip 535 out of the trailing gel tunnel 552 andinto the gel, thus coating the leading tip. This automatically coats theleading tip 535 when the catheter is removed from the packaging.

In a slightly different configuration, FIGS. 8A and 8B show a gelreceptacle 640 surrounded by a rigid outer container body 622. The gelreceptacle 640 is tubular as before and includes distal and proximalopenings 644, 646 preferably aligned along a centerline.

The body 622 has diametrically-opposed apertures 623 aligned with amid-section of the receptacle 640. The receptacle 640 has side walls 660that are deformable such that finger pressure on them through theapertures 623, as seen in FIG. 8B, closes the trailing gel tunnel 652 onthe leading tip 635 of the tube of the catheter 630 to ensure gelcoating of the leading end. The entire gel receptacle 640 may be made ofthe deformable material, such as being molded of silicone rubber, orjust the side walls 660 thereof, or just a portion of the side walls.This embodiment serves to improve coating of the leading tip 635 as withthe other embodiments, but requires a secondary action and is thus notautomatic like the others.

FIGS. 9A and 9B are perspective views of an alternative gel receptacle700 that is similar to the gel receptacle 140 seen in FIGS. 3A and 3B.The gel receptacle 700 may be positioned in a catheter container 20 inplace of the gel receptacle 40 shown and described above with referenceto FIGS. 1 and 2A-2B, or in other configurations of catheter packagingwhich require withdrawal of the catheter from the container for use.Alternatively, the gel receptacle 700 may be housed in a more flexiblecontainer, or as a standalone device within a flexible package such as abag.

The gel receptacle 700 also has a cavity 702 filled with a lubricantgel, a chamfered distal opening 704 formed in a distal end wall, and aproximal opening 706 formed in an outwardly tapered conical proximal endwall 708, through both of which the tube of a catheter 710 passes.Namely, a leading tip 712 of the catheter 710 extends beyond the distalopening 704, while a proximal end of the catheter having an outletfunnel 716 is stored adjacent the proximal opening 706. As with theprior art, withdrawal of the catheter in a proximal direction pulls theleading tip 712 through the gel receptacle 700 to coat it withlubricating gel.

In contrast to the prior art, the openings 704, 706 are laterally offsetfrom each other, such as forming one or both offset relative to alongitudinal centerline of the gel receptacle 700. In the illustratedembodiment, the distal opening 704 is offset in one lateral directionfrom the longitudinal centerline, while the proximal opening 706 isconcentric with the longitudinal centerline, as seen in FIG. 10A withthe urinary catheter 710 in a stored configuration therein.Consequently, the flexible tube of the catheter 710 deflects wheninserted through the two openings 704, 706 to form the slightly bentshape shown.

FIG. 10B shows the gel receptacle during retraction of the cathetertherefrom. When the catheter leading end 712 passes through the gelreceptacle 700 during withdrawal, a gel tunnel 720 thus formed behindit. However, due to the offset openings 704, 706, once the leading end712 is retracted past the distal opening 704 it tends to be displacedlaterally due to the inherently elastic nature of the catheter tube.This ensures the leading end 712 diverges from the tunnel 720 and intothe lubricating gel, automatically coating the leading tip when thecatheter is removed from the packaging.

FIGS. 11A and 11B are perspective views of an alternative gel receptacle750 that is similar to the gel receptacle 540 seen in FIGS. 7A and 7B.As before, the gel receptacle 750 may be positioned in a rigid cathetercontainer 20 such as described above, or may be housed in a moreflexible container, or as a standalone device within a flexible packagesuch as a bag.

The gel receptacle 750 also has a cavity 752 defined within a generallycylindrical outer body 753 having a chamfered distal opening 754 formedin a distal end wall, and a proximal opening 756 formed in an outwardlytapered conical proximal end wall 758, through both of which the tube ofa catheter passes. The gel receptacle 750 has an internal spring fingeror flap 760 to ensure gel coating of the leading end. The finger 760 isshown angled radially and axially inward from a proximal corner of thereceptacle 750, though its placement and orientation may be altered. Thelength and angle of the finger 760 is such that it permits insertion ofthe tube of the catheter in a distal direction when assembling thecatheter container, and exerts a radially inward force to the catheter.As seen in FIG. 11E, the inner edge 764 of the finger 760 has a shallow“W-shape” this purpose will be explained below.

Prior to a discussion of the function of the gel receptacle 750, FIG.12A is a perspective view of a single-use package 770 containing aurinary catheter 772 stored with the gel receptacle therein. The package770 may comprise a flexible elongated sterile bag that accommodates anelongated catheter 772 bent 180°, typical for male use. Catheters forfemale use are typically smaller, requiring a smaller package and acatheter that is stored straight. The user simply tears open the bag 770such that the catheter 772 and gel receptacle 750 are ready for use.

FIGS. 12B and 12C show the urinary catheter 772 stored within the gelreceptacle 750 and being removed therefrom, respectively. A leading tip774 of the catheter 772 extends beyond the distal opening 754, while aproximal end of the catheter having an outlet funnel 776 is storedadjacent the proximal opening 756. As with the prior art, withdrawal ofthe catheter in a proximal direction pulls the leading tip 774 throughthe gel receptacle 750 to coat it with lubricating gel.

When the catheter 772 is withdrawn, as shown in FIG. 12B, the leadingtip 774 thereof eventually clears the distal opening 754. The bias forceof the spring finger 760 displaces the leading tip 774 out of a trailinggel tunnel 778 and into the gel, thus coating the leading tip. Thisautomatically coats the leading tip 774 when the catheter is removedfrom the packaging. The W-shaped inner edge 764 provides a convexcentral curve which contacts the catheter 772 so as to bias the catheterwithout removing too much of the gel.

FIGS. 13A and 13B are perspective views of a further gel receptacle 780having a collapsible indented section 782 that helps automatically applygel to a urinary catheter during withdrawal therefrom, while FIGS.14A-14D are several additional views. The gel receptacle 780 preferablydefines an elastomeric hollow body having a cylindrical proximal end 784and a cylindrical distal end 786 flanking the indented section 782. Aprotruding conical wall 788 defines a proximal opening 790, while aradially-oriented wall 792 forms a distal opening 794. The indentedsection 782 comprises opposed flat walls 796 that extend along the axissubstantially the whole length of the gel receptacle 780 and are spacedapart as seen best in FIG. 14C so as to define an inner cavity 795therebetween. Each of the opposed flat walls 796 has one or moreinwardly-facing protrusions 798 whose purpose will be described below.

FIG. 15A is a perspective view of another single-use package 800containing a urinary catheter 802 stored with the gel receptacle 780shown in FIGS. 13-14. Again, the package 800 may comprise a flexibleelongated sterile bag that accommodates the elongated catheter 802 bent180°, typical for male use. The user simply tears open the bag 800 suchthat the catheter 802 and gel receptacle 780 are ready for use.

FIGS. 15B and 15C show the urinary catheter 802 stored within the gelreceptacle 780 and being removed therefrom, respectively. The innercavity 795 is filled with a lubricant gel after insertion of thecatheter 802 through the receptacle 780. A proximal funnel 804 on thecatheter abuts the conical wall 788 at the proximal opening 790, while adistal tip 806 extends beyond the distal opening 794. The presence ofthe catheter tube 808 within the gel receptacle 780 contacts the inwardprotrusions 798 and forces the flat walls 796 of the indented section782 outward. This enlarges the volume of the cavity 795 which is thenfilled with gel. A user grasps the gel receptacle 780 in one hand andpulls the funnel 804 with the other hand relative thereto to withdrawthe catheter tube 808 through the gel receptacle. As seen in FIG. 15C,the elastomeric nature of the walls 796 of the indented section 782cause them to flex inward after removal of the supporting catheter tube808. This forces gel over the distal tip 806, evenly coating thecatheter tube 808.

Although the gel receptacle 780 is preferably formed from an elastomericmaterial such as silicone rubber, at a minimum the gel receptacle ismade of a deformable material adapted to collapse inward during catheterwithdrawal. That is, the entire receptacle may be elastomeric, or justthe indented portion 782. Further, the indented portion 782 may besimply flexible, such as being formed of a thin polypropylene layer suchas in plastic bags, which is pulled inward by suction when the cathetertube 808 is removed from the receptacle. The various such configurationsand combinations are contemplated.

FIGS. 16A and 16B are perspective views of a still further collapsiblegel receptacle 820 that helps apply gel to a urinary catheter, whileFIGS. 17A-17D are several orthogonal and sectional views. The gelreceptacle 820 has a collapsible indented section 822 similar to thatdescribed above with respect to the receptacle 780. The indented section822 is flanked by a cylindrical proximal section 824 and a cylindricaldistal section 826, each of which has respective openings 828, 830.Although the collapsible indented section 822 is shown closer to thedistal end of the receptacle 820, it could also function the same iflocated at the proximal or exit end of the receptacle.

In contrast with the earlier embodiment, the indented section 822 doesnot extend substantially the whole axial length of the receptacle 820,but only approximately one half the length, and the proximal section 824is substantially longer than the distal section 826. As before, and asseen best in FIG. 17C, the shortened indented section 822 is formed by apair of opposed flat walls 832 each of which has at least oneinwardly-directed protrusion 834. Although not shown, a urinary cathetertube extending through the gel receptacle 820 contacts the protrusions834 and forces the elastomeric walls 832 outward, thus increasing thevolume within the receptacle 820. The inner cavities are then filledwith the gel and the catheter and receptacle are packaged as describedabove. When the consumer desires to use the catheter, he simply pullsthe catheter from the receptacle which allows the walls 832 to collapseinward, thus distributing gel evenly around the distal tip of thecatheter. As before, the collapsible section 822 may be formed of anelastomeric material, or at least a deformable material that collapsesinward upon catheter withdrawal.

FIGS. 18A-18C show another gel receptacle 840 having a collapsibleportion 842 with inner fins. The receptacle 840 is a substantiallycylindrical hollow member with a proximal opening 844, a distal opening846, and an inner cavity therebetween. The collapsible portion 842comprises a plurality (preferably 4) of scallops or concave wallsections 848 adjacent the distal opening 846 each of which has aradially-directed inner fin 850. The fins 850 project inward toward eachother as seen in FIGS. 18B and 18C. At least the concave wall sections840 of the receptacle 840 are elastomeric (though the entire gelreceptacle 840 may be elastomeric), such that when the catheter extendsthrough the proximal and distal openings 844, 846 it contacts the fins850 and expands the receptacle.

FIGS. 19A and 19B are longitudinal sectional views of the gel receptacle840 with a catheter 860 stored therein and being removed therefrom,respectively. Initially, the catheter 860 forces the concave wallsections 848 outward, which creates more volume within the receptaclewhich is then filled with gel 862. As the catheter 860 is retractedproximally, as seen in FIG. 19B, it no longer contacts the fins 850 andthe elastomeric wall sections 840 are allowed to collapse inward, thusensuring good gel coverage on a distal tip 864 of the catheter 860. Asmentioned above, the collapsible section 842 or the entire receptacle840 may be formed of an elastomeric material, the collapsible section842 comprises a deformable material that collapses inward upon catheterwithdrawal.

Throughout this description, the embodiments and examples shown shouldbe considered as exemplars, rather than limitations on the apparatus andprocedures disclosed or claimed. Although many of the examples presentedherein involve specific combinations of method acts or system elements,it should be understood that those acts and those elements may becombined in other ways to accomplish the same objectives. Acts, elementsand features discussed only in connection with one embodiment are notintended to be excluded from a similar role in other embodiments.

It is claimed:
 1. A method of producing an intermittent urinary catheterpackage, comprising: a) providing an intermittent urinary catheterhaving a flexible catheter tube with a distal tip and at least onedischarge opening proximate the distal tip, and a catheter outletprovided at a proximal end of the catheter tube, b) providing a gelreceptacle defining a cavity therein and having a distal opening at adistal end with an inner diameter corresponding to a catheter tubediameter, and a proximal opening at a proximal end with an innerdiameter larger than the catheter tube diameter, wherein a side wall ofthe gel receptacle is made of a deformable material and configured tocollapse inward in a relaxed state to a collapsed shape, c) insertingthe catheter distal tip through the proximal opening, cavity and out ofthe distal opening of the gel receptacle to a stored position so as todeform the side wall outward from the collapsed shape to an enlargedshape, in the process enlarging the cavity, d) filling the enlargedcavity of the gel receptacle with a lubricating agent gel so that thegel surrounds a portion of the catheter tube within the cavity, whereinwithdrawing the catheter distal tip proximally from the stored positionin the gel receptacle permits the side wall of the gel receptacle tocollapse inward to the collapsed shape so as to coat the distal tip ofthe catheter tube with the lubricating agent gel, and e) sealing thegel-filled gel receptacle and catheter within an inner space of an outercontainer.
 2. The method of claim 1, wherein the deformable material issilicone rubber.
 3. The method of claim 1, wherein the outer containerhas a rigid main body and the gel receptacle is held in an inner spaceof the main body, wherein the main body has diametrically-opposedapertures that expose the side wall of the gel receptacle such that auser may manually depress the side wall inward.
 4. The method of claim1, wherein the side wall has at least one inward projection whichextends inward into contact with the catheter tube in its storedposition.
 5. The method of claim 4, wherein there are at least twoopposed inward projections which extend inward into contact withopposite side of the catheter tube in its stored position and hold theside wall away from the catheter tube to create a volume within the gelreceptacle for receiving the lubricating agent gel.
 6. The method ofclaim 5, wherein the side wall and inward projections extendsubstantially the entire length of the gel receptacle.
 7. The method ofclaim 5, wherein the side wall and inward projections extend along lessthan half of the length of the gel receptacle.
 8. The method of claim 5,wherein the side wall and inward projections are formed adjacent thedistal end of the gel receptacle and the side wall comprises a series ofcircumferentially spaced concave portions and the inward projectionscomprise radial fins attached thereto.
 9. The method of claim 1, whereinthe gel receptacle is shaped so as to have at least one inward bulge onone side which extends into a straight line path for the catheter tubeextending between the distal and proximal openings.
 10. The method ofclaim 1, wherein the outer container comprises a flexible, sterile bagand the catheter and gel receptacle are the only items within the bag.11. The method of claim 1, wherein the gel receptacle has a cylindricalproximal end and a cylindrical distal end flanking an indented sectionformed by opposed flat walls that extend along a proximal-to-distal axissubstantially the whole length of the gel receptacle.
 12. The method ofclaim 11, wherein the inward projections extend inward from the opposedflat walls and projections from one wall are offset from projectionsfrom the opposed wall.
 13. The method of claim 12, wherein the distaland proximal openings of the gel receptacle are aligned along a centralaxis thereof, and the inward projections extend inward in their relaxedstates across the central axis.
 14. The method of claim 1, wherein thegel receptacle has a cylindrical proximal end and a cylindrical distalend flanking an indented section formed by opposed flat walls thatextend along a proximal-to-distal axis approximately one-half of thelength of the gel receptacle.
 15. The method of claim 14, wherein theinward projections extend inward from the opposed flat walls andprojections from one wall are offset from projections from the opposedwall.
 16. The method of claim 15, wherein the distal and proximalopenings of the gel receptacle are aligned along a central axis thereof,and the inward projections extend inward in their relaxed states acrossthe central axis.
 17. The method of claim 1, wherein the catheter outletcomprises a funnel secured to a proximal end of the catheter tube, andthe gel receptacle proximal opening is defined by a protruding conicalwall having a smaller diameter than a distal end of the funnel.